CA2464502C - Granules ou poudre servant a preparer des agents d'enrobage et des liants pour formes pharmaceutiques - Google Patents

Granules ou poudre servant a preparer des agents d'enrobage et des liants pour formes pharmaceutiques Download PDF

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Publication number
CA2464502C
CA2464502C CA2464502A CA2464502A CA2464502C CA 2464502 C CA2464502 C CA 2464502C CA 2464502 A CA2464502 A CA 2464502A CA 2464502 A CA2464502 A CA 2464502A CA 2464502 C CA2464502 C CA 2464502C
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CA
Canada
Prior art keywords
granules
powders
pharmaceutical
powder
active compound
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Expired - Lifetime
Application number
CA2464502A
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English (en)
Other versions
CA2464502A1 (fr
Inventor
Hans-Ulrich Petereit
Christian Meier
Erna Roth
Andreas Gryczke
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Individual
Original Assignee
Roehm GmbH Darmstadt
Evonik Operations GmbH
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Roehm GmbH Darmstadt, Evonik Operations GmbH filed Critical Roehm GmbH Darmstadt
Publication of CA2464502A1 publication Critical patent/CA2464502A1/fr
Application granted granted Critical
Publication of CA2464502C publication Critical patent/CA2464502C/fr
Anticipated expiration legal-status Critical
Expired - Lifetime legal-status Critical Current

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1682—Processes
    • A61K9/1694—Processes resulting in granules or microspheres of the matrix type containing more than 5% of excipient
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605—Excipients; Inactive ingredients
    • A61K9/1629—Organic macromolecular compounds
    • A61K9/1635—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1682—Processes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A61K9/2806—Coating materials
    • A61K9/2833—Organic macromolecular compounds
    • A61K9/284—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone
    • A61K9/2846—Poly(meth)acrylates
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/50—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
    • A61K9/5005—Wall or coating material
    • A61K9/5021—Organic macromolecular compounds
    • A61K9/5026—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates

Landscapes

  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Animal Behavior & Ethology (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Medicinal Preparation (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Coloring Foods And Improving Nutritive Qualities (AREA)
  • General Preparation And Processing Of Foods (AREA)

Abstract

L'invention concerne un procédé pour fabriquer des granules ou une poudre servant de couverture ou de liant à des formes médicamenteuses d'administration orale ou cutanée, pour des compléments cosmétiques ou alimentaires, lesdites granules ou ladite poudre étant composées des éléments suivants : (a) un copolymère, constitué d'esters C1 à C4 à polymérisation radicalaire des acides acrylique ou méthacrylique ainsi que d'autres monomères (méth)acrylate contenant des groupes amine tertiaire fonctionnels, (b) 3 à 25 % en poids, relativement à (a), d'un émulsifiant dont la balance hydrophile/lipophile est d'au moins 14, (c) 5 à 50 % en poids, relativement à (a), d'un acide monocarbonique C12 à C18 ou d'un composé hydroxylé C12 à C18. Les éléments (a), (b) et (c) sont mélangés simultanément ou successivement, éventuellement avec addition d'un agent pharmaceutique actif et/ou d'autres additifs usuels, puis ils sont fondus et malaxés dans un mélangeur chauffant, la masse fondue ainsi obtenue étant alors refroidie et réduite en granules ou en poudre.
CA2464502A 2002-08-27 2003-07-08 Granules ou poudre servant a preparer des agents d'enrobage et des liants pour formes pharmaceutiques Expired - Lifetime CA2464502C (fr)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
DE10239999A DE10239999A1 (de) 2002-08-27 2002-08-27 Granulat oder Pulver zur Herstellung von Überzugs- und Bindemitteln für Arzneiformen
DE10239999.9 2002-08-27
PCT/EP2003/007319 WO2004019918A1 (fr) 2002-08-27 2003-07-08 Granules ou poudre pour la preparation de couverture ou de liant pour des formes medicamenteuses

Publications (2)

Publication Number Publication Date
CA2464502A1 CA2464502A1 (fr) 2004-03-11
CA2464502C true CA2464502C (fr) 2010-11-23

Family

ID=31197526

Family Applications (1)

Application Number Title Priority Date Filing Date
CA2464502A Expired - Lifetime CA2464502C (fr) 2002-08-27 2003-07-08 Granules ou poudre servant a preparer des agents d'enrobage et des liants pour formes pharmaceutiques

Country Status (16)

Country Link
US (1) US7175857B2 (fr)
EP (1) EP1432409B1 (fr)
JP (1) JP4571861B2 (fr)
KR (1) KR100942667B1 (fr)
AT (1) ATE408401T1 (fr)
AU (1) AU2003266232A1 (fr)
BR (1) BRPI0306143B8 (fr)
CA (1) CA2464502C (fr)
DE (2) DE10239999A1 (fr)
ES (1) ES2314275T3 (fr)
IL (2) IL161145A0 (fr)
IN (1) IN2004CH00875A (fr)
MX (1) MX250472B (fr)
PL (1) PL206233B1 (fr)
SI (1) SI1432409T1 (fr)
WO (1) WO2004019918A1 (fr)

Families Citing this family (38)

* Cited by examiner, † Cited by third party
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DE10208344A1 (de) 2002-02-27 2003-09-04 Roehm Gmbh Schmelzextrusion von Wirkstoffsalzen
DE10260921A1 (de) * 2002-12-20 2004-07-01 Röhm GmbH & Co. KG Verfahren zum Überziehen von Substraten für pharmazeutische Anwendungen mit einem Gemisch aus zwei filmbildenden Überzugsmitteln
DE10260920A1 (de) * 2002-12-20 2004-07-01 Röhm GmbH & Co. KG Verfahren zur Herstellung von Arnzeiformen oder Nahrungsergänzungsmitteln mit pigmentierten Polymerüberzügen
DE10260919A1 (de) * 2002-12-20 2004-07-01 Röhm GmbH & Co. KG Verfahren zur Herstellung von überzogenen Arzneiformen und Nahrungsergänzungsmitteln mit Konzentrationsgradienten im Überzug
DE10304403A1 (de) * 2003-01-28 2004-08-05 Röhm GmbH & Co. KG Verfahren zur Herstellung einer oralen Arzneiform mit unmittelbarem Zerfall und Wirkstofffreisetzung
DE102004029573A1 (de) * 2004-06-18 2005-12-29 Gambro Lundia Ab MIF-Adsorbent
WO2006046560A1 (fr) * 2004-10-29 2006-05-04 Taiho Pharmaceutical Co., Ltd. Préparation orale particulaire contenant de la propivérine et procédé de fabrication de ladite préparation
EP1681049A1 (fr) * 2005-01-12 2006-07-19 Physica Pharma Composition pharmaceutique et forme galénique correspondante à délitement rapide en bouche, et procédé de fabrication de cette composition
BRPI0611272A2 (pt) * 2005-05-03 2011-11-16 Mutual Pharmaceutical Co formulações de quinina
DE102005042039A1 (de) * 2005-09-02 2007-03-08 Basf Ag Wässrige Polyvinylacetatdispersionen mit hoher Scherstabilität
DK2046300T3 (da) * 2006-08-04 2010-07-26 Ethypharm Sa Oralt desintegrerende multilagstablet
JP5632282B2 (ja) 2007-08-02 2014-11-26 ビーエーエスエフ ソシエタス・ヨーロピアＢａｓｆ Ｓｅ Ｎ，ｎ−ジエチルアミノエチルメタクリラートをベースとする水性ポリマーディスパージョン、その調製及び使用
WO2010030735A2 (fr) * 2008-09-11 2010-03-18 Aethos Pharmaceuticals, Inc. Enrobage stabilisé destiné à des formulations pharmaceutiques
US9254329B2 (en) 2009-10-28 2016-02-09 Basf Se Stable protective coatings for pharmaceutical dosage forms
US20110150986A1 (en) * 2009-12-18 2011-06-23 Kristin Arnold Quinine formulations, method of making, and metho of use thereof
CA2792647A1 (fr) * 2010-03-10 2011-09-15 Nogra Pharma Limited Compositions pour le lavage du colon et procedes de preparation et d'utilisation de celles-ci
JP2013526495A (ja) 2010-05-10 2013-06-24 エボニック レーム ゲゼルシャフト ミット ベシュレンクテル ハフツング １種以上の抗レトロウイルス活性成分を有する製薬学的剤形
WO2012031934A1 (fr) 2010-09-07 2012-03-15 Basf Se Utilisation de copolymères à base de polymères contenant des groupes amino en tant que liants matriciels pour la fabrication de granulés contenant des agents actifs et formes galéniques
US9795576B2 (en) 2010-09-27 2017-10-24 Basf Se Protective coatings for acidic active ingredients
JP6012604B2 (ja) 2010-09-27 2016-10-25 ビーエーエスエフ ソシエタス・ヨーロピアＢａｓｆ Ｓｅ 酸性有効成分のための保護コーティング
US8865250B2 (en) 2011-02-28 2014-10-21 Basf Se Production of pulverulent coating compositions for stable protective coatings for pharmaceutical dosage forms
US8962064B2 (en) 2011-02-28 2015-02-24 Basf Se Production of pulverulent coating compositions for stable protective coatings for pharmaceutical dosage forms
BR112013021510B1 (pt) 2011-02-28 2020-09-24 Basf Se Processo para a produção de composições de revestimento em pó, e, uso de um pó de polímero
BR112013020877B1 (pt) 2011-02-28 2020-06-02 Basf Se Processo para produzir composições de revestimento pulverulentas
US9044734B2 (en) 2011-09-23 2015-06-02 Basf Se Diesel oxidation catalyst with layered structure containing ceria composition as palladium support material for enhanced HC and CO gas conversion
EP2636403A1 (fr) * 2012-03-09 2013-09-11 Basf Se Fabrication de revêtements de protection pharmaceutiques ayant une bonne résistance en milieu neutre
US20130236505A1 (en) 2012-03-09 2013-09-12 Basf Se Production Of Pharmaceutical Protective Coatings With Good Resistance In A Neutral Environment
CN104379174B (zh) 2012-06-22 2018-01-26 巴斯夫欧洲公司 基于甲基丙烯酸二乙基氨基乙酯共聚物的含活性成分固体分散体
US10668156B2 (en) 2012-06-22 2020-06-02 Basf Se Active-ingredient-containing solid dispersions based on diethylaminoethyl methacrylate copolymers
US20150290136A1 (en) * 2012-11-22 2015-10-15 Evonik Roehm Gmbh Process for preparing a granulated product from a powder composition
FR3027802B1 (fr) * 2014-10-31 2018-03-02 Ethypharm Granules de principe actif a double masquage de gout, leur procede de preparation et comprimes orodispersibles les contenant
GR1008992B (el) * 2015-12-17 2017-03-23 Verisfield (Uk) Ltd, Υποκαταστημα Ελλαδας, Εμπορια Φαρμακων Φαρμακευτικη συνθεση σε μορφη κοκκιων για χορηγηση απο το στομα που περιεχει μετρονιδαζολη ή παραγωγα αυτης και εναν παραγοντα καλυψης της γευσης
EP3569225A1 (fr) * 2018-05-18 2019-11-20 Pharmaceutical Oriented Services Ltd Dispersion solide contenant du ritonavir
JP7058763B2 (ja) * 2018-12-27 2022-04-22 興和株式会社 医薬品
CA3203975A1 (fr) 2020-12-03 2022-06-09 Battelle Memorial Institute Compositions de nanoparticules polymeres et de nanostructures d'adn et procedes d'administration non virale
CA3216359A1 (fr) 2021-04-07 2022-10-13 Battelle Memorial Institute Technologies de conception, de construction, de test et d'apprentissage rapides pour identifier et utiliser des vecteurs non viraux
AU2024353375A1 (en) 2023-09-29 2026-04-09 Battelle Memorial Institute Polymer nanoparticle compositions for in vivo expression of polypeptides
WO2025122954A1 (fr) 2023-12-08 2025-06-12 Battelle Memorial Institute Utilisation de nanostructures d'origami d'adn pour systèmes de stockage de données basés sur des informations moléculaires

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DE3581428D1 (de) 1984-06-13 1991-02-28 Roehm Gmbh Verfahren zum ueberziehen von arzneiformen.
DE3920082A1 (de) 1989-06-20 1991-03-07 Roehm Gmbh Filmbildendes waessriges ueberzugsmittel fuer feste arzneimittel, verfahren zu seiner herstellung und verwendung
DE29502547U1 (de) 1995-02-16 1995-03-30 Röhm GmbH, 64293 Darmstadt Thermoplastisches Überzugs- und Bindemittel für Arzneiformen
DE19918435A1 (de) * 1998-07-23 2000-01-27 Roehm Gmbh Überzugs- und Bindemittel für orale oder dermale Arzneiformen
DE19958007A1 (de) * 1999-12-02 2001-06-07 Roehm Gmbh Spritzgußverfahren für (Meth)acrylat-Copolymere mit teritiären Ammoniumgruppen
EP1311820B1 (fr) * 2000-07-14 2015-02-11 Janssen Diagnostics, LLC Amelioration de l'efficience de la separation par agregation controlee de nanoparticules magnetiques
JP4938204B2 (ja) * 2001-02-27 2012-05-23 エボニック レーム ゲゼルシャフト ミット ベシュレンクテル ハフツング 貯蔵安定性を改良するための、医薬品配合物用被覆材料および結合材料
DE10208344A1 (de) * 2002-02-27 2003-09-04 Roehm Gmbh Schmelzextrusion von Wirkstoffsalzen

Also Published As

Publication number Publication date
US20040249035A1 (en) 2004-12-09
JP2005536555A (ja) 2005-12-02
BRPI0306143B1 (pt) 2016-03-08
EP1432409B1 (fr) 2008-09-17
KR100942667B1 (ko) 2010-02-17
IN2004CH00875A (fr) 2006-01-13
JP4571861B2 (ja) 2010-10-27
PL368186A1 (en) 2005-03-21
US7175857B2 (en) 2007-02-13
US20050197434A9 (en) 2005-09-08
EP1432409A1 (fr) 2004-06-30
BRPI0306143B8 (pt) 2021-05-25
DE10239999A1 (de) 2004-03-04
MXPA04003970A (es) 2004-06-22
CA2464502A1 (fr) 2004-03-11
IL161145A (en) 2010-11-30
IL161145A0 (en) 2004-08-31
KR20050034620A (ko) 2005-04-14
MX250472B (es) 2007-10-17
WO2004019918A1 (fr) 2004-03-11
DE50310506D1 (de) 2008-10-30
ATE408401T1 (de) 2008-10-15
ES2314275T3 (es) 2009-03-16
AU2003266232A1 (en) 2004-03-19
SI1432409T1 (sl) 2009-02-28
PL206233B1 (pl) 2010-07-30
BR0306143A (pt) 2004-10-19

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Effective date: 20230710